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Pregnancy: For sugammadex, no clinical data on exposed pregnancies are available.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition, or postnatal development.
Caution should be exercised when administering sugammadex to pregnant women.
Breast-feeding: It is unknown whether sugammadex is excreted in human breast milk. Animal studies have shown excretion of sugammadex in breast milk. Oral absorption of cyclodextrins in general is low and no effect on the suckling child is anticipated following a single dose to the breast-feeding woman.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from sugammadex therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: The effects of sugammadex on human fertility have not been investigated. Animal studies to evaluate fertility do not reveal harmful effects.
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